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| Name | Class |
|---|---|
| Enovate Biolife Pvt Ltd | INDUSTRY |
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Sexual function is a part of a normal healthy life and considered to be essential for mental, physical and marital well-being. Any derangement in normal function though is a distressing situation for the individual, is often not reported due to embarrassment or due to social stigma. Sexual disorders in men are categorized according to the stage of sexual response affected in terms of disorders of erectile function, ejaculatory function or libido, albeit there is considerable potential for overlap amongst the disorders. The use of current intervention has many side-effects and has been prohibited in cardiovascular condition and also to be taken with caution with other medical condition.
This has led to the development of multiple alternate therapies which are helpful for a limited number of cases but the major concern for all these therapies is their late onset of action and not having a sustained effect.
Enovate Biolife is trying to improvise further their already marketed product HeezOn® by adding new botanicals thus naming it HeezOn Ultra. HeezOn®has been studied on 148 subjects and has proven to be beneficial for subjects with mild to moderate ED. The previous study fell short to capture the data for subjects who were also suffering from PE and their overall quality of life-related to sexual health. Therefore, the trial is designed to study the speedy and sustained effect of the improvised formula on different aspects of sexual dysfunctions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HeezOn Ultra-1 | Active Comparator | HeezOn Ultra-1 includes ingredients like Shilajit, Galangal, Fenugreek. Dose: 2 capsules daily half an hour before dinner to be taken orally for 21 days. |
|
| HeezOn Ultra-2 | Active Comparator | HeezOn Ultra-2 includes ingredients like Arjuna, Galangal, Fenugreek. Dose: 2 capsules daily half an hour before dinner to be taken orally for 21 days. |
|
| Placebo | Placebo Comparator | Placebo consists of Micro-crystalline Cellulose. Dose: 2 capsules daily half an hour before dinner to be taken orally for 21 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeezOn Ultra-1 | Other |
| ||
| HeezOn Ultra-2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in scores of Sexual Health Inventory for Men | Day 0, Day 1, Day 3, Day 14 and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual Hormone Binding Globulin | Day 0 and Day 14 | |
| Free Testosterone | Day 0 and Day 14 | |
| Change in scores of Sexual Quality of Life - Male |
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Inclusion Criteria:
Planning to have regular sexual activity (more than twice/ week).
Body Mass Index should be ≤ 29 kg/m2.
Subjects suffering from erectile dysfunction indicated by SHIMscore ≥ 12 and ≤ 16 for more than 3 months and less than 6 months.
OR
Subjects suffering from predominantly from premature ejaculation as indicated by PEDT score more than 11 for more than 3 months and less than 6 months.
Fasting blood sugar ≤ 120 mg/dl.
The subjects have to be non-smoker and non-alcoholic.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandip Patil, M.D. | Maharashtra Medical Council | Principal Investigator |
| Shirish Malde, BHMS | Maharashtra Council of Homoeopathy Mumbai | Principal Investigator |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D061686 | Premature Ejaculation |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| Placebo | Other |
|
| Day 0, Day 1, Day 3, Day 14 and Day 28 |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D000097910 | Ejaculatory Dysfunction |